MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035432080
Medical Device Problem Codes	Separation Failure (2547); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that after the coil (subject device ) was placed inside the aneurysm, it was attempted to be detached 5 times without success.During retraction of the coil delivery wire, the subject coil prematurely detached, placed inside the parent artery, and was managed to be placed back at the target site by pushing with the microcatheter and guidewire.The procedure was completed successfully without clinical consequences to the patient.
Additional Manufacturer Narrative
The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Information provided by the customer indicated that 5 attempts were made to detach the coil without success and the coil prematurely detached upon retraction in the parent artery.The coil was able to be placed at the target site by pushing with the microcatheter and guidewire and there was no injury to the patient.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, a cause of undeterminable will be assigned to the reported complaint.
Event or Problem Description
It was reported that after the coil (subject device ) was placed inside the aneurysm, it was attempted to be detached 5 times without success.During retraction of the coil delivery wire, the subject coil prematurely detached, placed inside the parent artery, and was managed to be placed back at the target site by pushing with the microcatheter and guidewire.The procedure was completed successfully without clinical consequences to the patient.

• Brand Name: TARGET HELICAL ULTRA 2MM X 8CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9865530
• Report Number: 3008881809-2020-00068
• Device Sequence Number: 561063
• Product Code: HCG
• UDI-Device Identifier: 04546540676023
• UDI-Public: 04546540676023
• Combination Product (Y/N): N
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0035432080
• Device Catalogue Number: M0035432080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INZONE DETACHMENT SYSTEM (STRYKER); INZONE DETACHMENT SYSTEM (STRYKER)